Search Results
Found 1 results
510(k) Data Aggregation
(329 days)
LIQUIBAND FLOW CONTROL
LiquiBand Flow Control topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Flow Control topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand® Flow Control is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for wound closure. LiquiBand® Flow Control is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within 30 seconds. The device is contained within a PET/tyvek blister
This document is a 510(k) Pre-market Notification for a topical skin adhesive (LiquiBand Flow Control) and as such focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving their fulfillment through extensive clinical studies. Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable or detailed in this type of submission.
However, I can extract information related to the comparative testing performed to demonstrate substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The submission demonstrates substantial equivalence based on a comparison to predicate devices rather than specific quantitative acceptance criteria with predefined thresholds for each test. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate devices in the listed tests.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Tensile strength (ASTM F2255-05, F2258-05, F2458-05) | Demonstrated substantially equivalent performance to predicate devices |
| Set (polymerization) time | Demonstrated substantially equivalent performance to predicate devices |
| Heat of polymerization | Demonstrated substantially equivalent performance to predicate devices |
| Viscosity | Demonstrated substantially equivalent performance to predicate devices |
| GC Chemical Analysis | Demonstrated substantially equivalent performance to predicate devices |
| Force to actuate | Demonstrated substantially equivalent performance to predicate devices |
| Biocompatibility (ISO 10993) | Safe and biocompatible for intended use, substantially equivalent to predicates |
| Sterilization (SAL 10⁻⁶ by ebeam) | Same as predicate LiquiBand (K083531) |
| Shelf Life | 18 months (supported by real-time and accelerated stability data) |
2. Sample size used for the test set and the data provenance
The document does not specify detailed sample sizes for each of the nonclinical tests (tensile strength, set time, etc.). These are typically laboratory-based tests. Data provenance is implied to be from internal testing by the manufacturer (Advanced Medical Solutions (Plymouth) Ltd.), which would generally be considered proprietary and therefore not explicitly detailed in terms of country of origin for each test dataset, nor whether it's retrospective or prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are nonclinical, laboratory-based functional and chemical analyses, not requiring expert ground truth in the medical imaging or diagnostic sense.
4. Adjudication method for the test set
Not applicable, as no expert review or adjudication process is described for these nonclinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a topical skin adhesive, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a topical skin adhesive, not an AI or algorithm-based device.
7. The type of ground truth used
For the nonclinical tests (tensile strength, polymerization time, etc.), the "ground truth" would be the measured physical and chemical properties of the device, assessed against established industry standards (e.g., ASTM standards for tensile strength) and compared to the properties of the predicate devices. For biocompatibility, the ground truth is the successful completion of ISO 10993 tests, demonstrating the absence of adverse biological reactions.
8. The sample size for the training set
Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set in the AI context.
Ask a specific question about this device
Page 1 of 1